(249 days)
The NucliSENS EasyQ Analyzer and the accompanying NucliSENS EasyQ Director software are intended for in vitro diagnostic use in conjunction with FDA-cleared or approved NucliSENS assay protocols. The user shall be a properly trained laboratory technician familiar with performing nucleic acid assays. The analyzer is intended to measure fluorescent readings from molecular beacon probes binding to amplified RNA or DNA in samples containing NucliSENS EasyQ assay reagents while controlling the temperature of the samples. The NucliSENS EasyQ Director software is intended to control instrument operations and organize the assays to be performed. In addition, the software is intended to automatically calculate results for each test request based on raw measurement data, the data reduction algorithm specified for the assay, and the batch parameters of the reagents used for the test.
The NucliSENS EasyQ System includes principally the instrument, NucliSENS EasyQ® Analyzer, and the software, consisting of NucliSENS EasyQ" Director Software 2.6 used in combination with assay specific NucliSENS EasyQ® assay protocols. The system also requires use of the instrument, NucliSENS EasyQ® Incubator II.
The NucliSENS EasyQ® Analyzer (Analyzer) is an automated, temperature-controlled fluorescence analyzer instrument designed for batch processing of up to 96 samples per run. Amplification of nucleic acid targets is detected by means of sequence-specific probes which each fluoresce upon binding of the probe to its target. The Analyzer contains a plate carrier, which is designed to keep temperature constant at the required assay temperature. The Analyzer is a specially designed fluorescent reader using an optical system based on direct and focused illumination, designed to prevent crosstalk, Specific filters are used to select the appropriate wavelength for both excitation and emission of the molecular beacons used in the assay specified for each test. The filter selection is controlled by the attached PC and is a function of the assay protocol applied to a specified test.
Once sample tube strips have been loaded into plate carrier block of the Analyzer, the instrument moves the first tube into position over the light source. The Analyzer the light source upward through the bottom of the sample tube. The light causes the molecular beacons (in the assay reagent mixture) to emit light. Through the use of a mirror, the emitted light is directed through an optical filter to a photomultiplier tube where the fluorescence reading is taken. The next sample is then moved into position and the process is repeated. The intensity of the emitted light is measured for each sample and the process is repeated for each test as the run progresses, generating a series of data points for each sample that form fluorescence curves.
The Analyzer is used in combination with NucliSENS EasyQ® Director software) and assay-specific EasyQ® assay protocol software (assay protocols), loaded on a NucliSENS EasyQ computer with a keyboard and screen interface. The Director Software is used for instrument control and data collection. In combination with assay-specific "assay protocols", the Director Software also performs automated result calculation and reporting based on the analysis of real-time fluorescence signal curves measured by the Analyzer. Results may be qualitative or quantitative, depending on the design of the assay and the assay protocol. Results available to the operator include both the qualitative or quantitative test result and the graph of the fluorescence data points (data curves).
This document describes the NucliSENS EasyQ® System, which includes the NucliSENS EasyQ® Analyzer and NucliSENS EasyQ® Director Software 2.6. The submission is for a 510(k) clearance, indicating a claim of substantial equivalence to a predicate device, rather than a novel device requiring extensive clinical trials for efficacy. The core of this submission focuses on changes to an already cleared system, specifically a software upgrade (Director 2.5 to 2.6) and an instrument replacement (EasyQ Incubator to EasyQ Incubator II).
Therefore, the "study" described is primarily a validation of these changes to maintain equivalence, not a standalone performance study of the entire system as a new device.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for performance metrics like sensitivity or specificity for the entire system as a new device. Instead, the submission hinges on the concept of substantial equivalence to an already cleared system (NucliSENS EasyQ® System with Enterovirus v1.1 Assay, K063261) and a predicate device (Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument, K082562).
For the changes in this submission (software upgrade and incubator replacement), the acceptance criterion is implied to be that the updated system performs equivalently to the previously cleared system, specifically with the NucliSENS EasyQ® Enterovirus v1.1 Assay.
| Acceptance Criterion (Implied for Changes) | Reported Device Performance (for validated changes) |
|---|---|
| Maintain equivalent performance to the previously cleared system (K063261) | "Validated by internal in-silico testing using a panel of input data selected from prior test results, and representative of all foreseeable classes of test specimens." |
Study Details for Device Performance
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "a panel of input data selected from prior test results." A specific number for this panel is not provided.
- Data Provenance: The data was "selected from prior test results," implying it was retrospective data. The country of origin is not specified but given bioMérieux's global presence, it's likely a multinational company with data potentially from various regions, though typically for regulatory submissions in the US, data is often from US or similar regulatory environments.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document implies an "internal in-silico testing" approach. There is no mention of a specific number of experts or their qualifications for establishing ground truth for this validation. The "prior test results" would have had their ground truth established during the original validation of the Enterovirus assay.
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Adjudication Method for the Test Set:
- No adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the validation was "internal in-silico testing" using pre-existing data.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted as part of this submission. The validation focused on the technical performance of the upgraded software and instrument, not a human-in-the-loop comparison.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the validation described as "internal in-silico testing" using a panel of input data effectively represents a standalone algorithm-only performance assessment for the software upgrade. It confirms the software's ability to correctly process existing data and calculate results as expected, without human interaction during that assessment phase.
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Type of Ground Truth Used:
- The ground truth for the test data (the "panel of input data selected from prior test results") would have been established previously for the NucliSENS EasyQ® Enterovirus v1.1 Assay. For nucleic acid amplification tests, this typically involves clinical diagnosis combined with confirmatory laboratory methods (e.g., culture, sequencing, or a validated reference PCR) to define true positive/negative samples. The document does not explicitly state the ground truth for these specific prior test results.
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Sample Size for the Training Set:
- The document describes "internal in-silico testing using a panel of input data selected from prior test results." This panel was used for validation of the changes (software and incubator). There is no mention of a separate "training set" size in this submission section, as the software is an upgrade, not a newly developed prediction algorithm that would typically require a distinct training phase in this context. The core data reduction algorithm itself would have been developed and "trained" during the original development of the NucliSENS EasyQ® Director Software, but details are not provided here.
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How the Ground Truth for the Training Set Was Established:
- As no specific "training set" for the software upgrade validation is mentioned, this information is not available in the provided text. The original software development would have relied on internally generated or retrospectively collected data with established outcomes or known characteristics (e.g., spiked samples, clinical samples with confirmed results), but these details are not part of this 510(k) summary.
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.